MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019— 510(k) K061135

Substantially Equivalent

Aesculap

FDA 510(k) clearance K061135 for MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019, Substantially Equivalent on 2006-07-11. Applicant: Aesculap.

Clearance details

Applicant: Aesculap
Product code: Code GWG
Advisory panel: Neurology
Date received: 2006-04-24
Decision date: 2006-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

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Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.